Aesthetic Plastic Surgery

, Volume 34, Issue 4, pp 413–422 | Cite as

Unacceptable Results with an Accepted Soft Tissue Filler: Polyacrylamide Hydrogel

  • Ali Manafi
  • Abol-Hasan Emami
  • Aydin H. Pooli
  • Mohammadali Habibi
  • Lila Saidian
Original Article

Abstract

Background

Polyacrylamide hydrogel, considered a safe and biocompatible soft tissue filler, is widely used in cosmetic procedures. Its use for facial contouring and breast augmentation in Iran has increased dramatically in recent years. Most patients and many doctors are unaware of possible and reported adverse effects related to its administration.

Methods

This study enrolled 98 patients experiencing unsatisfactory results and complications of polyacrylamide hydrogel. Adverse effects related to gel administration were documented for all the patients. Lab values were requested together with related medical care and surgical treatments, and gel was extracted by incision, milking, and irrigation.

Results

The most common findings at the time of presentation were inflammation (n = 51), asymmetry (n = 31), irregularity (n = 18), infection and abscess formation (n = 11), and gel migration (n = 8). In one patient, severe anaphylactoid reaction was observed 1 week after gel injection, which led to significant complications for the patient. Histologic findings showed granuloma formation (n = 17), fat necrosis (n = 9), and fibrosis (n = 17). Macroscopic gel-related complications resolved after extraction of the injected material, except for skin necrosis and hyperpigmentation, which remained unchanged. For eight patients, the gel could not be extracted by squeezing and irrigation entirely. Three patients experienced gel reaccumulation after seemingly complete removal of the gel.

Conclusions

A wide range of complications seen among our patients showed that polyacrylamide hydrogel may not be as safe and biocompatible as it was thought previously. Both patients and physicians must be aware of the potential side effects of polyacrylamide hydrogel before gel administration.

Keywords

Aesthetic surgery Polyacrylamide hydrogel Soft tissue augmentation Soft tissue filler 

References

  1. 1.
    McCollister DD, Hake CL, Sadek SE, Rowe VK (1965) Toxicologic investigations of polyacrylamides. Toxicol Appl Pharmacol 7:639–651CrossRefPubMedGoogle Scholar
  2. 2.
    Smith EA, Oehme FW (1991) Acrylamide and polyacrylamide: a review of production, use, environmental fate, and neurotoxicity. Rev Environ Health 9:215–228PubMedGoogle Scholar
  3. 3.
    Amended final report on the safety assessment of polyacrylamide and acrylamide residues in cosmetics. Int J Toxicol 24(2):21–50 (2005)Google Scholar
  4. 4.
    Breiting V, Aasted A, Jorgensen A, Opitz P, Rosetzsky A (2004) A study on patients treated with polyacrylamide hydrogel injection for facial corrections. Aesth Plast Surg 28:45–53CrossRefGoogle Scholar
  5. 5.
    Zarini E, Supino R, Pratesi G, Laccabue D, Tortoreto M, Scanziani E, Ghisleni G, Paltrinieri S, Tunesi G, Nava M (2004) Biocompatibility and tissue interactions of a new filler material for medical use. Plast Reconstr Surg 114:934–942CrossRefPubMedGoogle Scholar
  6. 6.
    de Cassia Novaes W, Berg A (2003) Experiences with a new nonbiodegradable hydrogel (Aquamid): a pilot study. Aesth Plast Surg 27:376–380CrossRefGoogle Scholar
  7. 7.
    Christensen LH, Breiting VB, Aasted A, Jorgensen A, Kebuladze I (2003) Long-term effects of polyacrylamide hydrogel on human breast tissue. Plast Reconstr Surg 111:1883–1890CrossRefPubMedGoogle Scholar
  8. 8.
    Christensen L, Breiting V, Janssen M, Vuust J, Hogdall E (2005) Adverse reactions to injectable soft tissue permanent fillers. Aesth Plast Surg 29:34–48CrossRefGoogle Scholar
  9. 9.
    Niechajev I (2000) Lip enhancement: surgical alternatives and histologic aspects. Plast Reconstr Surg 105:1173–1183 (discussion 1184–1177)CrossRefPubMedGoogle Scholar
  10. 10.
    Bello G, Jackson IT, Keskin M, Kelly C, Dajani K, Studinger R, Kim EM, Lincoln D, Silberberg B, Lee A (2007) The use of polyacrylamide gel in soft tissue augmentation: an experimental assessment. Plast Reconstr Surg 119:1326–1336CrossRefPubMedGoogle Scholar
  11. 11.
    De Santis G, Jacob V, Baccarani A, Pedone A, Pinelli M, Spaggiari A, Guaraldi G (2008) Polyacrylamide hydrogel injection in the management of human immunodeficiency virus-related facial lipoatrophy: a 2-year clinical experience. Plast Reconstr Surg 121:644–653CrossRefPubMedGoogle Scholar
  12. 12.
    von Buelow S, Pallua N (2006) Efficacy and safety of polyacrylamide hydrogel for facial soft-tissue augmentation in a 2-year follow-up: a prospective multicenter study for evaluation of safety and aesthetic results in 101 patients. Plast Reconstr Surg 118:85S–91SCrossRefGoogle Scholar
  13. 13.
    Zhao Y, Qiao Q, Yue Y, Kou X, Liu Z (2004) Clinical and histologic evaluation of a new injectable implant: hydrophilic polyacrylamide gel. Ann Plast Surg 53:267–272CrossRefPubMedGoogle Scholar
  14. 14.
    Goldan O, Georgiou I, Grabov-Nardini G, Regev E, Tessone A, Liran A, Haik J, Mendes D, Orenstein A, Winkler E (2007) Early and late complications after a nonabsorbable hydrogel polymer injection: a series of 14 patients and novel management. Dermatol Surg 33(Suppl 2):S199–S206 (discussion S206)PubMedCrossRefGoogle Scholar
  15. 15.
    de Bree R, Middelweerd MJ, van der Waal I (2004) Severe granulomatous inflammatory response induced by injection of polyacrylamide gel into the facial tissue. Arch Facial Plast Surg 6:204–206CrossRefPubMedGoogle Scholar
  16. 16.
    El-Shafey El-SI (2008) Complications from repeated injection or puncture of old polyacrylamide gel implant sites: case reports. Aesth Plast Surg 32:162–165CrossRefGoogle Scholar
  17. 17.
    Christensen L, Breiting V (2005) Complications induced by polyacrylamide hydrogen injection. Plast Reconstr Surg 116:1168–1169CrossRefPubMedGoogle Scholar
  18. 18.
    Christensen L, Breiting V (2006) Management of postoperative complications of breast augmentation by injected polyacrylamide hydrogel. Aesth Plast Surg 30:132CrossRefGoogle Scholar
  19. 19.
    Cohen JL (2008) Understanding, avoiding, and managing dermal filler complications. Dermatol Surg 34(Suppl 1):S92–S99CrossRefPubMedGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC and International Society of Aesthetic Plastic Surgery 2009

Authors and Affiliations

  • Ali Manafi
    • 1
  • Abol-Hasan Emami
    • 1
  • Aydin H. Pooli
    • 1
  • Mohammadali Habibi
    • 1
  • Lila Saidian
    • 1
  1. 1.Department of Plastic and Reconstructive SurgeryFatemeh Zahra Hospital, Iran University of Medical SciencesTehranIran

Personalised recommendations